ORTHOFIX GALAXY FIXATION SYSTEM 1 (REF 99-93502US)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242511298), received between Feb 28, 2021 and Feb 28, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K113770); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 99-93502US (TIBIA FEMUR DIAPHYSEAL STERILE KIT) - BATCH NUMBER: B1384578 - QUANTITY: 1 - DATE OF INITIAL SURGERY: (B)(6) 2021. - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA/ANKLE. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "AT TIME OF APPLICATION OF THE GALAXY PRODUCT, CODE 99-93502US, ALL PRODUCT WAS TIGHT. LATER IN THE DAY, THE DEVICE (CLAMPS), LOOSE AND LOST REDUCTION". THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. - PRODUCT IS AVAILABLE FOR RETURN. ON (B)(6), 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS FROM THE SALES REPRESENTATIVE: - DATE OF THE INIT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11390917 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113770. One submission often covers many models, so check the product and lot details in each record.

• Z-2729-2026 · Jun 10, 2026 · Open, Classified
  Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
• Z-2731-2026 · Jun 10, 2026 · Open, Classified
  Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
• Z-2730-2026 · Jun 10, 2026 · Open, Classified
  Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
• Z-2732-2026 · Jun 10, 2026 · Open, Classified
  Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
• Z-0400-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
• Z-0394-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
• Z-0398-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
• Z-0399-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
• Z-0402-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
• Z-0395-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
• Z-0401-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
• Z-0396-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
• Z-0397-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915